Events

Rappel de ALLSET GOLD ABDRQ LOW RESOLUTION KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par LIFE TECHNOLOGIES CORPORATION.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    31128
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-03-19
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Abc unitray ssp kits have a false negative in lane 13. internal investigation confirmed by sequence based typing that the customer had a sample type with a a*32:04 allele. therefore lane 13 has a confirmed false negative in the affected kits. however the primer mix in lane 13 is functioning as designed. the a*32:04 allele has an undefined sequence region which had not been confirmed through testing. the worksheet is incorrect in listing this allele as positive for lane 13.

Device

ALLSET GOLD ABDRQ LOW RESOLUTION KIT
  • Modèle / numéro de série
    Model Catalog: 54360D (Lot serial: 028 984379); Model Catalog: 54340D (Lot serial: 037 791458); Model Catalog: 54340D (Lot serial: 037 1099919); Model Catalog: 78100-10 (Lot serial: 035 757737); Model Catalog: 78100-10 (Lot serial: 035 709363); Model Catalog: 78100-10 (Lot serial: 035 841438); Model Catalog: 78100-10 (Lot serial: 035 1091909); Model Catalog: 78000-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78601-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78600-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78001-10 (Lot serial: > 10 contact manufacturer)
  • Description du dispositif
    Invitrogen AllSet Gold SSP HLA ABDRDQ Low Res Kits
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION